An interventional study of Probiotic and 10% dextrose in NEC and NEC - Necrotizing Enterocolitis, sponsored by Hayatabad Medical Complex. Active, not recruiting at 1 site in Pakistan. Open to participants aged Up to 1 Day, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Hayatabad Medical Complex · Not applicable, Interventional, and Prevention
The goal of the study is to check efficacy of probiotics in preventing necrotizing enterocolitis. The main questions would be if the preterm baby developed NEC or not.
: In the last five years, many systematic reviews have shown the benefit of Probiotics in prevention of NEC and Sepsis in preterm babies but most of these studies have been done in the developed countries. Although the overall benefit has been tilted In favor of use of probiotic however a definitive consensus has not been reached due to inconsistencies in results. Moreover, the impact of multistrain probiotics in our particular population has not been studied, which provides the rationale for our research
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 196 is above the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Hayatabad Medical Complex is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Infants with congenital or developmental gastrointestinal disorders for example omphalocele, malrotation, gastroschisis.
This group will receive intervention
Drug: Probiotic
This group will receive 10% DW
Drug: 10% dextrose
All preterm babies \<34 weeks Gestational age admitted within 24 hrs of life will be eligible for the study. Those full filling inclusion criteria and consenting to participate will be recruited. Consent will be obtained by team not caring for the patient. Each recruited patient will be assigned a case ID number. Based on the Randomization babies will be assigned to either the intervention group or control group. Study group: Multistrain probiotic containing a mix of Lactobacillus and Bifidobacterium spp. * Dose is 1 million international units (0.2ml or 5 drops) OD * Started as soon as feed is in initiated
Also known as: Multistrain Probiotic
This will receive 10% DW as placebo
Also known as: Dextrose water
Number of participants who develop NEC on probiotic vs placebo
Time frame: 30 days
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for Sep 2026, 5 months after the start.
Of 33 interventional studies with no phase under Enterocolitis, Necrotizing, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 59. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic
Hayatabad Medical Complex